Bloomlife, a women health technology company, has received two grants totaling $2.3 million that will be used to help fund a longitudinal study of its remote fetal monitoring wearable and also to expand development of the product.
“These grants allow us to further develop and validate our prenatal wearable platform for labor detection (preterm and term) and remote fetal monitoring, the two areas of greatest concern especially for high risk moms,” CEO Eric Dy wrote to MobiHealthNews in an email. “Building on these results, we will work closely with healthcare systems to integrate our solutions into clinical workflow.”
The product monitors electrical activity in the uterus. Pregnant women can place the device on their stomach using an adhesive strip. Users can connect the device to their smartphones and then see uterine activity. In the third trimester the device can also familiarize users with their contraction patterns. Currently the product is a direct-to-consumer offering.
A grant from the European Commission Horizon 2020 program will fund a longitudinal clinical study aimed to validate Bloomlife’s labor detection algorithm. The goal of the study is to detect the onset of labor remotely in expectant mothers during their third trimester, according to the press statement. Typically, expectant mothers have to travel to a clinic and see a physician to detect this. The study will take place over the next two year and will be run at multiple clinics.
The second grant will fund Bloomlife’s expansion of the monitoring product. Bloomlife will be partnering with Belgian based R&D institute imec to develop what it calls an ultra low-power noise circuit dedicated to tracking fetal ECG and fetal movement.
The grants are expected to fund development of fetal heart rate and movement capabilities. After these developments, the company said it intends to submit the device to the FDA for clearance.
Bloomlife, which was founded in 2014, is based in San Fransisco and has offices in Genk and Liege, Belgium. Both the Horizon 2020 Framework Programme of European Union and the Flanders Innovation and Entrepreneurship funding agency are based in Europe. Bloomlife said that, in addition to their goals to improve birth outcomes and lower healthcare costs, it aims to create jobs in Belgium and Europe at large.
“Fetal movement and fetal heart rate are the two indicators of fetal health today," Dr. Wilfried Gyselaers, principal investigator at Ziekenhuis Oost Limburg, a hospital in Genk, Belgium, said in a statement. "Unfortunately, fetal heart rate is limited to hospital settings, and there is no tool to objectively and accurately monitor fetal movement. We are excited to be part of the research to quantify fetal movements and fetal heart rate in ambulatory settings. The clinical relevance, for instance, is in pregnancies with growth retarded fetuses (+/- 5 percent) where we do not have any decent day-by-day monitoring today, is unquestionable."
The product is currently marketed as a tool for “peace of mind” and does not claim to diagnose, treat, migrate or prevent any disease or condition.
“Bloomlife was founded with the goal of empowering expectant moms and their care team with unprecedented level of insight to improve birth outcomes,” said Dy. “Through the most advanced combination of technology, medical expertise, and data science, Bloomlife aims to translate maternal and fetal health parameters into actionable information to better predict and manage pregnancy complications.”